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How to define New Equipment? Device is Returned, Refurbished or Repaired

S

SMCM94

#1
Hello all. I am in need of a bit of assistance.

Our organization recently acquired a medical device originally manufactured in Italy. During the transition process, I have discovered that the OEM maintained that a device retained it's "new" status for a period of 12 months once the original shipping carton has been opened. This is not the problem.

The hic-up comes when a "new" machine is returned prior to the 12 month period and then returned to the field, perhaps to a different customer. For example, a device could be shipped to a customer, who for one reason or another, decides not to keep the machine after 3 months. The device is returned, refurbished, and repaired, if necessary. That same device can than be sold or leased to a different customer as "new" with only 9 months remaining on the warranty for the new device.

I am concerned that there are regulatory and/or legal implications with labeling the returned device as "new" but I have not been unable to find any regulatory or legal guidance on this matter. So, I have nothing to support me when going up the ladder or am I just off base?

Any assistance would be greatly appreciated. Thank you.
 
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M

MIREGMGR

#3
For a transaction between US parties, this might be covered by the Uniform Commercial Code. You might talk with your attorney about that.

If the transaction was international, I have no idea.

USFDA doesn't define "new" as far as I know. It's fundamentally a business-law question, not within FDA's purview.
 

harry

Super Moderator
#4
In the commercial field over here, such issues are covered by the 'trade descriptions act'. One may be charged for fraud it they violate it. However, there are others who used this loop hole to import vehicles from overseas which had been registered earlier, may had their odometer tampered but sold to people who are willing to pay for it as if it is new. So, disclosure and willing buyer/willing seller may put you in a position out of reach by this particular act.

Sorry, I've no idea on the medical side too.
 
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